|Impax Submits New Drug Application for IPX066 in Parkinson’s Disease; VIVUS Reports Topline Findings From FORTRESS|
|By Staff and Wire Reports|
|Wednesday, 21 December 2011 19:06|
Impax Pharmaceuticals, the branded products division of Impax Laboratories, Inc. (NASDAQ: IPXL) announced the submission of Impaxs New Drug Application (NDA) for IPX066 to the U.S. Food and Drug Administration (FDA) for the treatment of idiopathic Parkinsons disease (PD). IPX066 is a patented extended release capsule formulation of carbidopa-levodopa (CD-LD). IPX066 is being developed in collaboration with GlaxoSmithKline (NYSE:GSK) for territories outside the U.S. and Taiwan.
In just three and a half years, Impaxs brand research and development team has successfully advanced IPX066 from an Investigational New Drug (IND) through multiple clinical studies of efficacy and safety, culminating in our NDA submission, said Michael Nestor, president of Impax Pharmaceuticals. This event demonstrates our strong internal capability to develop neurology products to fulfill unmet clinical needs of the PD community. IPX066 represents a significant commercial opportunity for Impax (IPXL) in the U.S., which if approved we plan to commercialize with our specialty neurology sales team.
IPX066 has undergone extensive clinical development, including multiple studies in early and advanced PD in the U.S. and in Europe. As agreed with the FDA, the NDA is being submitted as a 505(b)(2) application and includes data from three controlled Phase III studies and two open label extensions of IPX066 in early and advanced PD. In these studies, IPX066 has been studied in about 900 PD subjects. Impax held an end of Phase III meeting with the U.S. FDA in the third quarter of 2011 and is submitting its NDA consistent with the guidance it received.
VIVUS, Inc. (NASDAQ:VVUS) announced topline preliminary results from its retrospective study of medical claims data on oral clefts (OC) associated with topiramate exposure in utero. The study, known as FORTRESS for Fetal Outcome Retrospective TopiRamate ExpoSure Study, identified 1,945 mother-infant dyads exposed to topiramate either alone (monotherapy) or in combination with other antiepileptic agents (polytherapy) in the first trimester of pregnancy (the "Total Topiramate Cohort").
Among the Total Topiramate Cohort, 1,740 dyads were exposed to topiramate monotherapy (the "Topiramate Monotherapy Cohort"). There were 5 oral clefts in the Topiramate Monotherapy Cohort for a prevalence rate of 0.29% (5/1,740). This prevalence rate was compared to a control group of infants of women who had previously taken antiepileptic drugs including topiramate but not during the pregnancy of interest (the "Formerly Exposed Cohort"). The prevalence rate for the Formerly Exposed Cohort was 0.16% (21/13,512). The prevalence ratio for Topiramate Monotherapy Cohort versus the Formerly Exposed Cohort was 1.88 (center-standardized, 95% CI 0.705.03).
"The prevalence ratio for oral clefts in FORTRESS is within the recently reported range for topiramate from several large studies," commented Peter Tam, president of VIVUS, Inc. "We have shared these results with the FDA. We continue to work closely with the FDA during their review of the NDA and as we prepare for the upcoming Advisory Committee meeting expected in the first quarter of 2012."
The FORTRESS study analyzed data from the Total Topiramate Cohort, the Formerly Exposed Cohort, and a second control group, infants of women with similar medical profiles to the Total Topiramate Cohort regardless of prior antiepileptic drug use (the "Similar Medical Profile Cohort"). The Similar Medical Profile Cohort contained 13,614 dyads. In the Total Topiramate, Formerly Exposed, and Similar Medical Profile Cohorts there were 7, 21 and 9 oral clefts, respectively, for a prevalence of 0.36%, 0.16%, and 0.07%. Prevalence ratios standardized by center were 2.36 (95% CI: 0.99-5.59) for Total Topiramate Cohort versus the Formerly Exposed Cohort, and 5.44 (95% CI: 2.03-14.61) for Total Topiramate Cohort versus Similar Medical Profile Cohort. Results standardized by propensity score and site as well as results adjusting for other covariates, one at a time, yielded very similar results. One data source reported an unexpectedly low prevalence of oral clefts in the Similar Medical Profile Cohort.
To evaluate this finding, investigators conducted post-hoc analyses that involved repeated re-sampling from the group of dyads who were eligible for this cohort. Based on this re-sampling, the investigators determined that the oral clefts prevalence observed in the cohort was likely an artificially low estimate due to random error, suggesting that the observed prevalence ratio for the Total Topiramate Cohort versus the Similar Medical Profile Cohort is an over-estimate.
As part of FORTRESS, Major Congenital Malformations, or MCMs, are being evaluated. The MCM analysis is ongoing. The FORTRESS findings are based on a claims-only analysis. All of the results of the study are considered to be preliminary until the results are validated. The results will be final when validation is completed, which is expected in the third quarter of 2012.
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